CN115381591B - Straight-cylinder type superior vena cava bracket - Google Patents
Straight-cylinder type superior vena cava bracket Download PDFInfo
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- CN115381591B CN115381591B CN202210919327.3A CN202210919327A CN115381591B CN 115381591 B CN115381591 B CN 115381591B CN 202210919327 A CN202210919327 A CN 202210919327A CN 115381591 B CN115381591 B CN 115381591B
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- vena cava
- superior vena
- straight
- stent
- supporting
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- 210000002620 vena cava superior Anatomy 0.000 title claims abstract description 96
- 210000002489 tectorial membrane Anatomy 0.000 claims description 16
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 claims description 11
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 7
- 239000010410 layer Substances 0.000 claims description 5
- 229910000531 Co alloy Inorganic materials 0.000 claims description 3
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 3
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 claims description 3
- 229910045601 alloy Inorganic materials 0.000 claims description 3
- 239000000956 alloy Substances 0.000 claims description 3
- 229910052749 magnesium Inorganic materials 0.000 claims description 3
- 239000011777 magnesium Substances 0.000 claims description 3
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 claims description 3
- 239000002356 single layer Substances 0.000 claims description 3
- 239000010935 stainless steel Substances 0.000 claims description 3
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- 239000000463 material Substances 0.000 claims description 2
- 230000003247 decreasing effect Effects 0.000 claims 1
- 230000009286 beneficial effect Effects 0.000 abstract description 5
- 238000000576 coating method Methods 0.000 description 13
- 239000011248 coating agent Substances 0.000 description 12
- 210000004204 blood vessel Anatomy 0.000 description 8
- 239000012528 membrane Substances 0.000 description 5
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- 206010016717 Fistula Diseases 0.000 description 2
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000003890 fistula Effects 0.000 description 2
- 229960002897 heparin Drugs 0.000 description 2
- 229920000669 heparin Polymers 0.000 description 2
- 238000007757 hot melt coating Methods 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 229910052786 argon Inorganic materials 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000002008 hemorrhagic effect Effects 0.000 description 1
- 239000012943 hotmelt Substances 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Abstract
The invention belongs to the technical field of medical equipment, and particularly relates to a straight cylinder type superior vena cava bracket. The straight-cylinder type superior vena cava stent comprises a connecting beam and a plurality of supporting rings which are axially arranged; the adjacent support rings are fixedly connected through connecting beams; the support rings at the two ends of the straight cylinder type superior vena cava stent are respectively in a horn shape expanding towards the end parts. The straight cylinder type superior vena cava stent has good supporting force and radial force and better flexibility, is beneficial to ensuring the fit between the stent and the superior vena cava vessel wall and prevents the occurrence of internal leakage.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a straight cylinder type superior vena cava bracket.
Background
Among the devices on the market, there is no stent graft dedicated to the superior vena cava. Currently, in clinic, the via heparin coated stent is most commonly used by the FLUNENCY stent of the bard company.
The FLUNENCY covered stent is used as a self-expanding nickel-titanium alloy stent, can provide good supporting force and radial force in a blood vessel, can provide good supporting force in a straight section blood vessel to ensure the adhesion of the stent, and has limited application value in a curved section blood vessel because of the characteristic of 'hardness'.
The VIABAHN heparin coating tectorial membrane stent, as a flexible self-expanding nickel-titanium alloy stent, can provide better adherence in a small-angle bending section blood vessel and prevent internal fistula of the stent, but the smaller effective diameter also limits the application in a wider superior vena cava trunk.
A support for superior vena cava will guarantee certain holding power and radial force in the blood vessel simultaneously, also increase compliance characteristic and just can guarantee the laminating between support and the blood vessel wall better, prevent the emergence of internal fistula. However, no support can meet the requirements of the products on the market at present.
Accordingly, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
The invention aims to provide a straight cylinder type superior vena cava stent, which aims to solve the technical problem that a stent applied to a superior vena cava cannot meet the requirements on at least one of the supporting force, the flexibility and the effective diameter of the stent in the prior art.
In order to achieve the above object, the present invention provides the following technical solutions: a straight cylinder type superior vena cava stent comprises a connecting beam and a plurality of supporting rings which are axially arranged; the adjacent support rings are fixedly connected through connecting beams; the support rings at the two ends of the straight cylinder type superior vena cava stent are respectively in a horn shape expanding towards the end parts.
Preferably, the support ring comprises a plurality of support beams, and adjacent support beams are connected end to end in sequence.
Preferably, the end part of the straight cylinder type superior vena cava stent is provided with a developing ring fixing piece; the developing ring fixing piece is in a neck ring structure and is provided with a neck-shaped section and an annular section; the annular section is arranged at the end part of the straight-barrel type superior vena cava, and one end of the neck-shaped section, which is far away from the annular section, is provided with two connecting walls; the two connecting walls are fixedly connected with two adjacent supporting beams in the same supporting ring respectively; the developing ring is disposed at the neck section.
Preferably, in the same support ring: the adjacent supporting beams are sequentially connected end to end through the arc supporting tops, and the arc opening directions of the adjacent arc supporting tops are opposite; and the circular arc openings of the two nearest circular arc support tops are opposite in direction and positioned at different positions in the circumferential direction between the adjacent support rings.
Preferably, in the expanded state: the axial distance between adjacent support rings is 1/3-1/2 of the support beam; the circular arc diameter ratio of the circular arc supporting top is 1/3-1/2; the included angle between adjacent support beams is 50-70 degrees; the expansion rate of the supporting beam is 10% -20%; the diameter of the straight cylinder type superior vena cava stent is 16-18mm.
Preferably, two ends of the connecting beam are fixedly connected with the arc supporting tops of the adjacent supporting rings respectively; the connecting beam is any one of an S type, a Q type or a corrugated type.
Preferably, in the axial direction of the straight cylinder type superior vena cava stent, the number of the connecting beams is reduced and then increased.
Preferably, the support rings comprise end support rings and middle support rings, wherein the end support rings are connected with the adjacent support rings through 4 connecting beams, and any adjacent support rings of the middle support rings are connected through 2 connecting beams; in the middle support ring, the connecting beams between any adjacent support rings are distributed at different positions in the circumferential direction.
Preferably, the straight cylinder type superior vena cava stent is made of any one of stainless steel, cobalt-based alloy, platinum iridium alloy, nickel-titanium alloy or magnesium-based alloy; the straight cylinder type superior vena cava stent is made of a thin-wall pipe, the wall thickness of the thin-wall pipe is 0.15-0.25mm, and the outer diameter of the thin-wall pipe is 2.5-3mm.
Preferably, the straight cylinder type superior vena cava stent is a tectorial membrane stent; the covering film on the inner surface of the straight cylinder type superior vena cava stent is a single-layer ePTFE film; the covering film on the outer surface of the straight cylinder type superior vena cava stent is a double-layer ePTFE film; the tectorial membrane of the inner surface of the straight-tube type superior vena cava stent and/or the tectorial membrane of the outer surface of the straight-tube type superior vena cava stent are tubular; the thickness of the tectorial membrane on the inner surface of the straight-cylinder type superior vena cava stent and/or the tectorial membrane on the outer surface of the straight-cylinder type superior vena cava stent is larger than the wall thickness of the supporting ring.
The beneficial effects are that:
the straight cylinder type superior vena cava stent has good supporting force and radial force and better flexibility, is beneficial to ensuring the fit between the stent and the superior vena cava vessel wall and prevents the occurrence of internal leakage.
The diameter of the straight cylinder type superior vena cava stent can reach 16-18mm after expansion, the effective diameter is large, and the straight cylinder type superior vena cava stent is more suitable for superior vena cava lesion blood vessels; can be compressed in a 9F sheath tube, and has more market competitiveness.
The straight-tube type superior vena cava stent of the invention helps to prevent restenosis in the stent.
The arrangement of the developing ring of the straight cylinder type superior vena cava stent is beneficial to realizing the accurate release of the stent and preventing the developing ring from falling off.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. Wherein:
fig. 1 is a schematic structural diagram of a straight-tube type superior vena cava stent according to an embodiment of the invention after expansion (after coating);
fig. 2 is a schematic structural view (before coating) of a straight-tube type superior vena cava stent according to an embodiment of the invention;
FIG. 3 is a schematic view showing a connection structure between an end supporting ring and a developing ring fixing member of a straight-tube type superior vena cava stent according to an embodiment of the invention;
FIG. 4 is a schematic view of an expanded configuration of an end support ring and an intermediate support ring adjacent thereto of a straight-barrel superior vena cava stent according to an embodiment of the invention;
FIG. 5 is a schematic view showing the expanded configuration of adjacent 3 intermediate support rings of a straight-barrel type superior vena cava stent according to an embodiment of the invention;
in the figure:
1-a support ring; 2-ePTFE membrane; 3-connecting beams; 4-developing ring fixing member;
11-supporting beams; 12-arc supporting roof;
41-neck-shaped section; 42-ring segments.
Detailed Description
The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the invention, fall within the scope of protection of the invention.
The present invention will be described in detail with reference to examples. It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other.
It is to be understood that the terms "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate describing the invention and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus are not to be construed as limiting the invention.
In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
In the following stent pushing process, one end far away from an operator is a far end, and one end close to the operator is a near end.
The invention provides a straight cylinder type superior vena cava stent, which aims at solving the problems that no special coating stent for superior vena cava exists in the prior art and the requirements on the supporting force, the flexibility and the larger effective diameter of the stent cannot be met when the stent in the prior art is applied to the superior vena cava.
As shown in fig. 1-2, the straight-tube type superior vena cava stent of the embodiment of the invention comprises a connecting beam 3 and a plurality of supporting rings 1 which are axially arranged; the adjacent support rings 1 are fixedly connected through connecting beams 3; the support rings 1 at both ends (refer to the leftmost support ring 1 and the rightmost support ring 1 in fig. 1) are respectively horn-shaped expanding toward the end (refer to fig. 1, the leftmost support ring 1 expands leftwards, and the rightmost support ring 1 expands rightwards) in the axial direction of the straight-tube type superior vena cava stent. Wherein, the arrangement of the supporting ring 1 is helpful for the straight-tube type superior vena cava stent of the invention to have good supporting force and radial force; the arrangement of the connecting beam 3 is beneficial to ensuring that the stent has good flexibility and ensuring the fitting of the stent and the wall of the superior vena cava blood vessel; the support rings 1 at two ends (the support rings 1 at two ends comprise the support ring 1 at the proximal end and the support ring 1 at the distal end of the straight-tube type superior vena cava stent) are designed to be in a horn shape which is amplified towards the end, so that the adherence and the support of the straight-tube type superior vena cava stent of the invention are improved, and the stent is prevented from being shifted. The straight cylinder type superior vena cava stent can ensure that the stent has better support, radial force and flexibility under the condition of larger effective diameter (the diameter after expansion is 16-18 mm) so as to meet the use requirements of a flat section, a curved section and a trunk section of the superior vena cava.
Preferably, the horn shape of the support rings 1 at both ends can be formed into a horn shape at both ends of the stent (support rings 1 at both ends) after the cutting of the bare stent (stent before coating) is completed. The bare stent can be formed by cutting a 3mm nickel-titanium tube according to a cutting pattern and then shaping by heat treatment.
In the preferred embodiment of the present invention, the support ring 1 includes a plurality of support beams 11, and adjacent support beams 11 are connected end to end in sequence.
As shown in fig. 3, in the preferred embodiment of the present invention, the end of the straight-tube type superior vena cava stent is provided with a developing ring fixing member 4; the developing ring fixing member 4 is in a neck ring structure, and the developing ring fixing member 4 is provided with a neck section 41 and an annular section 42; the annular section 42 is arranged at the end part of the straight tubular superior vena cava (refer to fig. 1-3), and the end of the neck-shaped section 41 far away from the annular section 42 is provided with two connecting arms which are respectively fixedly connected with two adjacent supporting beams 11 in the same supporting ring 1; the developing ring is disposed at the neck section 41. By arranging the developing ring fixing member 4 at the end of the superior vena cava stent, the arrangement of the developing ring can be realized without affecting the uniformity of stent coating; the thickness of the covered stent after being pressed and held is convenient to be pressed and held into a sheath tube of 9F or less. The developing ring fixing member 4 has a neck ring structure, and the developing ring is provided on the neck section 41, which contributes to improvement of the stability of the fixing of the developing ring and prevention of the falling-off of the developing ring. In addition, through setting up the developing ring at the tip of support, conveniently form non-overlapping influence in the blood vessel to reach the purpose of locating support and observing the support release condition, realize the accurate release of support.
Preferably, 4 developing ring fixing members 4 (developing rings) may be provided at the proximal ends of the straight-tube type superior vena cava stent of the invention, respectively, the 4 developing ring fixing members 4 (developing rings) being uniformly distributed in the circumferential direction of the support ring 1; similarly, the distal end of the straight-tube type superior vena cava stent of the invention may also be provided with 4 developing ring fixtures 4 (developing rings), the 4 developing ring fixtures being uniformly distributed in the circumferential direction of the supporting ring 1.
In the preferred embodiment of the invention, the same support ring 1: the adjacent supporting beams 11 are sequentially connected end to end through the arc supporting tops 12, and the arc openings of the adjacent arc supporting tops 12 are opposite in direction; the circular arc openings of the two nearest circular arc support tops 12 are opposite in direction between the adjacent support rings 1. By reversing the circular arc opening directions of the two nearest circular arc support tops 12 between the adjacent support rings 1 and being located at different positions in the circumferential direction (i.e., the circular arc support tops 12 between the adjacent support rings 1 are offset from each other), it is possible to contribute to the increased flexibility of the bracket.
In a preferred embodiment of the invention, in the expanded state: the axial spacing between adjacent support rings 1 is 1/3-1/2 (e.g., 1/3, 2/5 or 1/2) of the support beam 11; the ratio of the circular arc diameters of the circular arc support roof 12 is 1/3-1/2 (e.g., 1/3, 2/5, or 1/2); the included angle between adjacent support beams 11 is 50-70 ° (e.g., 50 °, 55 °, 65 °, or 70 °); the expansion and contraction rate of the support beam 11 is 10% -20% (e.g., 10%, 15%, or 20%). Wherein, the axial distance between the adjacent support rings 1 (i.e. the projection length of the connecting beam 3 in the axial direction) is set to be 1/3-1/2 of the support beam 11, which is helpful for ensuring the expansion of the large diameter of the straight barrel type superior vena cava stent of the invention; the included angle between the adjacent support beams 11 is set to be 50-70 degrees (preferably 60 degrees) in the expanded state, so that the flexibility and stability of the expanded support can be guaranteed; the length of the support beam 11 should have flexibility, and the length should be determined by the diameter of the expanded support, and the expansion ratio should be between 10% and 20%.
In the preferred embodiment of the invention, the diameter of the expanded straight-cylinder type superior vena cava stent can reach 16-18mm (for example, 16mm, 17mm or 18 mm), the effective diameter is large, and the straight-cylinder type superior vena cava stent is more suitable for the characteristics of superior vena cava blood vessels; can be compressed within a 9F sheath.
In the preferred embodiment of the present invention, the spacing between any adjacent support rings 1 is equal on the axis of the straight superior vena cava stent of the present invention.
In the preferred embodiment of the invention, the length of the connecting beam 3, the length of the supporting beam 11, the circular arc diameter ratio of the circular arc supporting top 12 and the included angle theta between the adjacent supporting beams 11 in the same supporting ring 1 are set according to the proportion before and after compression and expansion, so that the overall consistency of the stent effect after stent expansion is ensured.
In the preferred embodiment of the invention, two ends of the connecting beam 3 are fixedly connected with the arc supporting tops 12 of the adjacent supporting rings 1 respectively; the connection beam 3 is any one of S-type, Ω -type, or corrugated type.
In the preferred embodiment of the invention, the number of the connecting beams 3 is reduced and then increased in the axial direction of the straight cylinder type superior vena cava stent. That is, the number of the connecting beams 3 at both ends is greater than that of the connecting beams 3 in the middle, so that both ends of the straight-tube type superior vena cava stent have better supportability, and the middle section maintains better flexibility (relative to the ends) while having a certain supportability.
As shown in fig. 4 to 5, in the preferred embodiment of the present invention, the support ring 1 includes an end support ring and an intermediate support ring, the end support ring (i.e., the support ring located at the most proximal or distal end of the stent) is connected to the adjacent support ring 1 through 4 connection beams 3 (the support of the end of the superior vena cava stent of a straight tube type is improved (refer to fig. 4), the intermediate support ring (i.e., the support ring located between the most proximal and distal ends of the stent) is connected between any adjacent support rings 1 through 2 connection beams 3, and the connection beams 3 between any adjacent support rings 1 are distributed at different positions in the circumferential direction (i.e., the connection beams 3 are distributed in a staggered manner, refer to fig. 5). By disposing 2 connection beams 3 at the intermediate support ring 1 and distributing the connection beams 3 at different positions in the circumferential direction, the flexibility is improved while the support of the stent is ensured.
In the preferred embodiment of the present invention, the material of the straight-tube type superior vena cava stent is any one of stainless steel, cobalt-based alloy, platinum iridium alloy, nickel-titanium alloy or magnesium-based alloy (preferably nickel-titanium alloy).
Preferably, the straight-barrel superior vena cava stent of the invention is made of a thin-walled tubing having a wall thickness of 0.15-0.25mm (e.g., 0.15mm, 0.20mm, or 0.25 mm) and an outer diameter of 2.5-3mm (e.g., 2.5mm, 2.8mm, or 3 mm).
In the preferred embodiment of the invention, the straight cylinder type superior vena cava stent is a tectorial membrane stent; the inner surface of the straight cylinder type superior vena cava stent is a single-layer ePTFE membrane 2; the outer surface of the straight cylinder type superior vena cava stent is a double-layer ePTFE membrane 2.
Wherein, the coating can be realized by a hot melt mode. For example, after the inner layer and the outer layer of the bare stent (stent before the coating) are respectively sleeved into the ePTFE membrane 2, the bare stent is put into a proper mold, a certain compression force is given, argon is introduced into a muffle furnace for protection, oxidation reaction in the coating process is prevented, the melting point of the ePTFE is reached, the bare stent is treated at 425 ℃ for 20min for heat melting shaping, and the bare stent is naturally cooled, so that the bare stent is finally formed into the coated stent. By adopting the form of ePTFE hot-melt coating, the preparation is more suitable for the hemorrhagic lesions of the superior vena cava, can block tumors and can prevent restenosis in the stent.
In the preferred embodiment of the invention, the tectorial membrane on the inner surface of the straight-cylinder type superior vena cava stent and the tectorial membrane on the outer surface of the straight-cylinder type superior vena cava stent are tubular, so that the problems of uneven tectorial membrane thickness and shrinkage in the tectorial membrane process are avoided, and the microscopic performance of the stent after the tectorial membrane is influenced.
In a preferred embodiment of the present invention, the thickness of the coating on the inner surface of the straight superior vena cava stent and/or the coating on the outer surface of the straight superior vena cava stent is greater than the wall thickness of the support ring 1 (i.e., at least one of the coating on the inner surface and the coating on the outer surface is greater than the wall thickness of the support ring 1) to help avoid the possible occurrence of incomplete ePTFE membranes after the hot melt coating. Wherein the wall thickness of the support ring= (outer diameter of the support ring-inner diameter of the support ring)/2.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. The straight-tube type superior vena cava stent is characterized by comprising a connecting beam and a plurality of supporting rings which are axially arranged;
the support rings comprise a plurality of support beams, the adjacent support beams are connected end to end in sequence, and the adjacent support rings are fixedly connected through connecting beams;
the support rings at the two ends of the straight cylinder type superior vena cava stent are respectively in a horn shape expanding towards the end parts;
the end part of the straight cylinder type superior vena cava stent is provided with a developing ring fixing piece;
the developing ring fixing piece is of a neck ring structure and is provided with a neck-shaped section and an annular section, the annular section is arranged at the end part of the straight-cylinder type superior vena cava, and the neck-shaped section is composed of two separated arms;
the two separated arms are fixedly connected with two adjacent supporting beams in the same supporting ring respectively;
the developing ring is disposed at the neck section.
2. The straight superior vena cava stent of claim 1, wherein in the same support ring: the adjacent supporting beams are sequentially connected end to end through the arc supporting tops, and the arc opening directions of the adjacent arc supporting tops are opposite;
and the circular arc openings of the two nearest circular arc support tops are opposite in direction and positioned at different positions in the circumferential direction between the adjacent support rings.
3. The straight superior vena cava stent of claim 2, wherein in the expanded state:
the axial distance between adjacent support rings is 1/3-1/2 of the support beam;
the circular arc diameter ratio of the circular arc supporting top is 1/3-1/2;
the included angle between adjacent support beams is 50-70 degrees;
the expansion rate of the supporting beam is 10% -20%;
the diameter of the straight cylinder type superior vena cava stent is 16-18mm.
4. The straight-tube type superior vena cava stent according to claim 2, wherein two ends of the connecting beam are fixedly connected with the arc supporting tops of the adjacent supporting rings respectively;
the connecting beam is any one of an S type, an omega type or a corrugated type.
5. The straight superior vena cava stent of claim 1, wherein the number of connection beams is decreased and then increased in the axial direction of the straight superior vena cava stent.
6. The straight-tube type superior vena cava stent according to claim 5, wherein the supporting rings comprise end supporting rings and middle supporting rings, the end supporting rings are connected with the adjacent supporting rings through 4 connecting beams, and any adjacent supporting rings of the middle supporting rings are connected through 2 connecting beams;
in the middle support ring, the connecting beams between any adjacent support rings are distributed at different positions in the circumferential direction.
7. The straight-tube type superior vena cava stent according to claim 1, wherein the material of the straight-tube type superior vena cava stent is any one of stainless steel, cobalt-based alloy, platinum iridium alloy, nickel-titanium alloy or magnesium-based alloy;
the straight cylinder type superior vena cava stent is made of a thin-wall pipe, the wall thickness of the thin-wall pipe is 0.15-0.25mm, and the outer diameter of the thin-wall pipe is 2.5-3mm.
8. The straight superior vena cava stent of any of claims 1-7, wherein the straight superior vena cava stent is a stent graft;
the covering film on the inner surface of the straight cylinder type superior vena cava stent is a single-layer ePTFE film;
the covering film on the outer surface of the straight cylinder type superior vena cava stent is a double-layer ePTFE film;
the tectorial membrane of the inner surface of the straight-tube type superior vena cava stent and/or the tectorial membrane of the outer surface of the straight-tube type superior vena cava stent are tubular;
the thickness of the tectorial membrane on the inner surface of the straight-cylinder type superior vena cava stent and/or the tectorial membrane on the outer surface of the straight-cylinder type superior vena cava stent is larger than the wall thickness of the supporting ring.
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| CN111938868A (en) * | 2020-08-20 | 2020-11-17 | 昆明市延安医院 | A device for treating severe pulmonary hypertension with patent ductus arteriosus and method of using the same |
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| CN100591385C (en) * | 2003-04-30 | 2010-02-24 | 尼普洛株式会社 | Extendable soft stent with excellent follow-up capability to blood vessel |
| CN102462563B (en) * | 2010-11-12 | 2015-11-11 | 上海微创医疗器械（集团）有限公司 | A kind of Furcated blood vessel stent |
| JP6622914B2 (en) * | 2015-07-23 | 2019-12-18 | オプティメド メディツィニッシェ インストゥルメンテ ゲーエムベーハーＯｐｔｉｍｅｄ Ｍｅｄｉｚｉｎｉｓｃｈｅ Ｉｎｓｔｒｕｍｅｎｔｅ Ｇｍｂｈ | Stent |
| CN106137484A (en) * | 2016-08-01 | 2016-11-23 | 江苏大学 | A kind of self-expansion type conical blood vessel support |
| US10849769B2 (en) * | 2017-08-23 | 2020-12-01 | Vesper Medical, Inc. | Non-foreshortening stent |
| CN208404997U (en) * | 2017-10-26 | 2019-01-22 | 柏为（武汉）医疗科技股份有限公司 | Vein blood vessel is from swollen bracket |
| WO2019096158A1 (en) * | 2017-11-17 | 2019-05-23 | 杭州唯强医疗科技有限公司 | Endovascular stent |
| CN212234805U (en) * | 2020-09-29 | 2020-12-29 | 杭州诺谊医疗科技有限公司 | Venous valve support and venous valve prosthesis |
| CN112472360A (en) * | 2020-11-25 | 2021-03-12 | 四川大学华西医院 | Vena cava stent |
| CN112914800A (en) * | 2021-01-22 | 2021-06-08 | 广州易介医疗科技有限公司 | Novel dense net support |
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| CN111938868A (en) * | 2020-08-20 | 2020-11-17 | 昆明市延安医院 | A device for treating severe pulmonary hypertension with patent ductus arteriosus and method of using the same |
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